```

[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103836-103838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30230]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3379]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Laboratory 
Accreditation for Analyses of Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 21, 2025.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information

[[Page 103837]]

collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0898. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Laboratory Accreditation for Analysis of Foods

OMB Control Number 0910-0898--Extension

    This information collection helps to support implementation of 
FDA's statutory and regulatory authority governing our laboratory 
accreditation for analysis of foods program under section 422 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350k) and 21 CFR part 
1, subpart R. FDA has statutory authority to establish a program for 
the testing of food by accredited laboratories; to establish a publicly 
available registry of recognized accreditation bodies and laboratories 
recognized by an accreditation body; and to require reports of any 
changes that would affect the recognition of such accreditation body or 
the accreditation of such laboratory.
    The regulations require respondents to maintain and electronically 
submit certain test results, reports, notifications, and other records 
to FDA. We are clarifying that the information collection includes the 
use of an electronic information collection system (the FURLS 
Laboratory Accreditation for Analyses of Foods Program portal) (FDA 
Industry Systems). User guides for the Accreditation Bodies and 
Accredited Laboratories can be found at the following links: https://www.fda.gov/media/156097/download?attachment and https://www.fda.gov/media/161685/download?attachment. The laboratory accreditation program 
helps fulfill FDA's mandate to ensure the safety of the U.S. food 
supply and protect U.S. consumers by administering appropriate 
oversight of certain food testing that is of importance to public 
health. It also helps ensure that the testing is done in accordance 
with appropriate model standards, which will help produce consistently 
reliable and valid test results. You may access additional information 
about the laboratory accreditation program at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program. The public 
registry is available at https://datadashboard.fda.gov/ora/fd/laaf.htm.
    Respondents to the information collection are accreditation bodies 
seeking recognition from FDA, recognized accreditation bodies, 
laboratories seeking accreditation from recognized accreditation 
bodies, and accredited laboratories. Participation in this program is 
voluntary for laboratories and accreditation bodies; however, only 
recognized accreditation bodies would be able to accredit laboratories 
to conduct food testing as specified in the regulations.
    In the Federal Register of August 15, 2024 (89 FR 66417), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1--Estimated Annual Reporting Burden\1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR section; activity        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113 and                      8              44             352  2.2068 (2 hours            776.8
 1.1114; Accreditation bodies                                                    and 12 minutes).
 (ABs) application for
 recognition (one-time
 submission).
Sec.  Sec.   1.1113 and
 1.1114; ABs--application for
 renewal of recognition.
Sec.   1.1123; ABs--reports,
 notifications, and
 documentation requirements.
Sec.   1.1116(a) and (b); ABs--              1               3               3  3...............               9
 notices of intent to
 relinquish, records custodian.
Sec.  Sec.   1.1138 and                    160            63.5          10,160  1.8051 (1 hour            18,340
 1.1139; laboratories--                                                          and 49 minutes).
 submission of application for
 LAAF-accreditation (one-time
 submission).
Sec.  Sec.   1.1149(a) and
 1.1152(c)(1), (2);
 laboratories--submission of
 sampling plan, sample
 collection report, and
 sampler qualifications.
Sec.  Sec.   1.1152(d) and
 1.1153(a); laboratories--
 qualification to submit
 abridged analytical reports
 (one-time submission).
Sec.   1.1153; laboratories--
 abridged analytical reports
 submissions.
Sec.   1.1149(c);
 laboratories--advance notice
 of sampling submissions.
Sec.   1.1152(f);
 laboratories--immediate
 notification.
Sec.   1.1140(a);                            2               3               6  1...............               6
 laboratories--notices of
 intent to relinquish, records
 custodian.
Sec.   1.1152(c)(4) and (5);                50               5             250  1.5 (1 hour and              375
 laboratories--validation and                                                    30 minutes).
 verification studies
 submissions.
Sec.  Sec.   1.1142; 1.1171;                 1               1               1  1...............               1
 1.1173; and 1.1174; requests
 in response to FDA action.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............          10,772  ................          19,508
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 103838]]

 
\2\ Totals may not sum due to rounding.

                              Table 2--Estimated Annual Recordkeeping Burden\1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.   1.1113; recordkeeping                 8               2               8  22..............             176
 associated with ISO/IEC
 17011:2017.
Sec.   1.1124; ABs--additional
 recordkeeping requirements a
 recognized accreditation body
 must maintain, for 5 years
 after the date of creation of
 the records, records created
 while it is recognized
 demonstrating its compliance
 with this subpart.
Sec.   1.1138; laboratories--                9               1               9  91.06 (91 hours              820
 becoming accredited to ISO/                                                     and 4 minutes).
 IEC 17025:2017 (one-time);
 Laboratories adding ISO 17025
 to become LAAF-accredited.
Sec.   1.1138; laboratories--              160               2             320  450.765 (450             144,245
 maintaining ISO/IEC 17025:                                                      hours and 46
 2017 accreditation.                                                             minutes).
Sec.   1.1154; laboratories--
 additional recordkeeping
 requirements; a LAAF-
 accredited laboratory must
 maintain, for 5 years after
 the date of creation, records
 created and received while it
 is LAAF-accredited that
 relate to compliance with
 this subpart.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............             345  ................         145,241
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    The burden we attribute to reporting and recordkeeping activities 
is assumed to be distributed among the individual elements of the 
respective information collection activities. Although we have not 
received a notice of intent to relinquish records since the last 
approval of this information collection, we include one response for 
the purpose of estimating burden.
    We calculate the number of food testing laboratories seeking 
accreditation based on the number of applicants. As a result, the 
number of respondents to the information collection decreased (from 170 
respondents in the currently approved collection to 160 respondents). 
Consequently, we have adjusted our burden estimate, which results in a 
decrease of 227 responses and 9,303 burden hours from the currently 
approved information collection.

    Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30230 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
```